GUEST COLUMNISTS

• Analyzing And Managing CDMO Project Risks Using Causal Mechanism & Effect Analysis

  Since every sponsor–CDMO relationship can have widely different scopes, requirements, and procedures, this article focuses on the basic principles for analyzing and managing the risks of not achieving the relationship’s objectives.

• Achieving Annex 1 Compliance In Sterile Manufacturing, Part 3: Building A Compliant Program

  In this third and final article of this series, let's take a closer look at what a well-constructed Annex 1-compliant program looks like at each stage, from gap assessment through governance.

• Mapping Early-Phase Supply Chain Bottlenecks That Doom Pipelines

  Many sponsors miscast preclinical development as an unglamorous step between discovery and the clinic. Here's how the consequences may lead to irrevocable losses.

• Achieving Annex 1 Compliance In Sterile Manufacturing, Part 2: Objective Measurement Tools

  Let's examine the objective measurement tools that directly address each of the gaps between Annex 1 expectations and what drug manufacturing facilities can currently demonstrate in practice.

• FDA Explains How To Respond To Form 483 Observations In New Draft Guidance

  In March 2026, the FDA issued a new draft guidance titled Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection Guidance for Industry. Let's take a closer look.

• Achieving Annex 1 Compliance In Sterile Manufacturing, Part 1: Common Compliance Failures

  A persistent gap remains between what Annex 1 requires and what facilities can demonstrate. Let's take a closer look at four common compliance failures.

• EMA's New Guideline For Synthetic Peptides: A More Explicit CMC Playbook For A Growing Therapeutic Class

  The European Medicines Agency’s Guideline on the Development and Manufacture of Synthetic Peptides, adopted in Dec. 2025 and effective from June 1, 2026, is an important regulatory development for peptide manufacturers.

• PUPSIT In Cell & Gene Therapy: Risk Reduction Or Operational Complexity?

  Few topics introduced by Annex 1 have generated as much discussion as pre-use post-sterilization integrity testing (PUPSIT). I share key considerations for cell and gene therapies.